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Dalester,

A thought provoking post with some interesting opinions - thanks.

I keep reading on bio boards that the FDA are biased against overseas sponsors of trials but nobody has ever actually been able to give an example or any evidence, it's all just been a general feeling. If there really was an issue, there should be a noticeable difference between new drug approvals from the European regulators and the FDA, with the EMA approving far more European drugs than the FDA - but there isn't. There's actually a very high degree of alignment between decisions from the FDA and the EMA and so it's hard to see how these claims of bias can be justified.

Whether the FDA are biased or not, it shouldn't be beyond the reach of Scancell to run a small clinical trial in the US - other small bios manage it all of the time and if they want to maximise their potential in terms of valuations and generating interest from 3rd parties then it's important that they're able to deal with the regulators covering the biggest market in the world. After all, it was Scancell themselves who told shareholders that they intended to become a late stage development company with a strong US presence.

Having said all of that, I agree that if they had known they'd be waiting for 4 years for FDA approval for the SCIB1 trial then I'm sure they'd have just run it in the UK and we'd be sitting here discussing the results now.

A great article on Ugur Sahin, explaining his success with Ganymed and BioNtech was published a couple of weeks ago.

https://www.lifescienceleader.com/doc/how-one-professor-built-two-billion-dollar-biotechs-0001

Yep, lots of potential but no matter what we think, Scancell have to provide the proof so they need to get those trials going. It's 5 years since Scancell recruited a patient to a clinical trial and 4 years since SCIB1 trial was first scheduled to start.

Crumbs,

I know we've seen before research demonstrating that Moditope generates immunological memory - so mice with melanoma are vaccinated with Modi1 which clears the tumour. When the mice are completely tumour free, they are re-challenged with the same tumour type, reject the tumour and demonstrate superior survival without the need for further vaccination. ie. they have immunological memory responses .

May have missed it, but I don't remember Scancell previously treating mice with one tumour type and then re-challenging with a different type of cancer. So in the paper published yesterday mice with melanoma were treated with Modi1 and when tumour free were re-challenged with lung cancer and showed 'a significant delay in tumor growth' compared to unvaccinated mice. This suggests that when Moditope is administered for one type of cancer, it offers protection against other tumours expressing cit. Vimentin and Enolase. I know that's always been the theory but good to see some research backing up the theory.

………..and beware of bb's where only super positive posts are tolerated.

The very best and most credible bb's are those where all aspects of a stock, good and bad are allowed to be freely discussed.

Crumbs/Ray/WTP

Interesting to read the comments regarding selection of peptides. You can't just find 3 different peptides that individually produce a good immune response and then combine them. There's a risk of them competing with each other and actually reducing the anti tumour response. So different combinations have to be tested to avoid immunodominance of one of the peptides. Hadn't crossed my mind before and highlights how involved and complex this whole process is.

By the way, I think this paper comes from the same research presented in a poster last year in Paris - see link below for poster 'Targeting citrullinated vimentin and enolase with cytotoxic CD4 T cells, relies upon MHC-II expression by tumors, reduces myeloid suppressor cells and directly kills tumor cells'

https://www.scancell.co.uk/cicon-international-cancer-immunotherapy-conference-paris-25-28-september-2019

Think the research in this paper is linked to the poster presented at the CRI-CIMT-EATI-AACR conference in Paris last September.

WTP - apologies posts crossed

Inanaco, would be good to get a reply to my 13.17 at some stage.

In the meantime, some new peer reviewed research from Lindy Durrant and her team was published yesterday in the Journal for Immunotherapy of cancer (follow link below to download PDF).

'Combination vaccine based on citrullinated vimentin and enolase peptides induces potent CD4-mediated anti-tumor responses'

'Modi-1 citrullinated peptide vaccine induces potent CD4- mediated anti- tumor responses in mouse models and a CD4 T cell repertoire is present in ovarian cancer patients to the citrullinated peptides suggesting that Modi-1 could be an effective vaccine for ovarian'

https://jitc.bmj.com/content/8/1/e000560.info

Ciaskin,

Excellent response and thanks for taking the time and trouble to share

Inanaco, - care to enlighten us? How do you continually buy?

Ray - thanks for the correction

Inanaco - care to enlighten us? How do you continuously buy?

Inanaco,

Just read your 9.20. I'm not suggesting that a regulatory RNS was required - this is exactly the sort of thing RNS REACH is designed to help with.

Inanaco,

……….but it's not business as usual, we know that. Cancer clinical trails have been halted so at the very least there would have been a hold on SCIB1 trial. Was there any impact on Moditope manufacture? Was Ichor still able to manufacture and supply Trigrid devices? Was there any impact on any of the collaborations with Avidimab/BioNTech? Were US clinical trial sites and investigators still willing and able to negotiate opening US sites for SCIB1? Were all Scancell employees fully occupied and were they working from home or were some furloughed? If they were working from home, was it a smooth transition? What is the likely impact on cash flow? There are plenty of unanswered questions and at the very least we should have been told that the SCIB1 trial was halted - shareholders would have understood and appreciated the Company taking the time and trouble to keep them informed. Instead, apart from the Covidity announcements there has been nothing.

As I say, it's just my opinion but updates in my other stocks have been very favourably received by shareholders.

Think we need to distinguish between PR and IR when it comes to the core pipeline. It's only worth spending time and resources on PR if you've actually got something to say, something positive to announce. No matter how promising the potential, waiting to enter clinical trials, waiting for something to come from one of the collaborations, waiting, waiting, etc. doesn't quite cut it and would be a complete waste of time and energy. Much better to have a PR drive as and when there's something concrete to announce like clinical trial results, a commercial deal etc.

However, IR from the BOD has been poor over recent months. I think without exception, every stock in my portfolio has kept shareholders informed regarding the effects of COVID-19 on their business and exactly what steps they are taking to minimise any impact. It's a great shame that Scancell haven't done the same. It hardly makes you feel valued as a shareholder.

So IMO, it's unfair to criticise CH for lack of PR for the core pipeline as he can only go down that road when the product development teams give him something to shout about. IR for retail investors has been sadly lacking and we can only hope that he's been concentrating on communicating with institutional investors. All just IMO of course.

BTW Crumbs, thanks for earlier link. good to see investors as well as Government/philanthropic organisations backing COVID vaccines.

Crumbs,

Re. the word 'enhance' - but isn't that exactly what an adjvant is/does? ie. to improve/enhance/boost immune response?

Anyway, as you say, time will tell and seems whatever these peptides are, Covidity won't be using a gene gun or electroporation which is a positive IMO.

Crumbs,

The full quote

'The Nottingham scientists are about to start work with peptides - small proteins - to enhance the vaccine.
It would mean doing away with the gold pellet, but they hope it will still be the silver bullet against COVID-19.'

The gold pellet is the gold nanoparticle gene gun delivery system, so these peptides seem to be connected with adjuvant/delivery system. Worth noting that SCIB1 requires 3 initial doses at 3 weekly intervals followed by regular 3 monthly dosing for up to 2 years. That dosing regime clearly wouldn't work with a COVID-19 vaccine, so I assume that they are trying to tailor the immune response to minimise the doses or even better achieve a single dose vaccine.

How — and When — Can the Coronavirus Vaccine Become a Reality? - link below is a well written and easily digested article that gives some perspective re. COVID vaccines. For those here with an interest beyond Scancell's project, it's well worth a read.

https://www.propublica.org/article/how-and-when-can-the-coronavirus-vaccine-become-a-reality

Inanaco,

We have already discussed that post at least twice and it's so tedious that you have yet again gone to the trouble of trawling back through my posts and reposting it.

Yet again, I will explain that my comments about the gulf between the Oxford and Scancell vaccines referred to the differences in stages of development - that's why I clearly stated ' there's a gulf between them IN DEVELOPMENT TERMS'

What issue can you possibly have with that comment? You must surely accept that as the Oxford vaccine is currently in phase III trials that there is indeed a gulf between ChAdOx1 and Covidity.

Far from pushing nonsense, I was simply trying to bring a little objectivity in answer to concerns from holders here that Scancell would never receive funding because it wasn't part of the Oxbridge elite. If you think I'm wrong then that has rather dire consequences for Scancell doesn't it?

Inanaco,

You have just accused me of pushing nonsense - can you explain exactly what you mean?

Could be but looking at other preclinical drug names, as 2cvguy has mentioned, it could well be S for Scancell and N for Nottingham. God knows about the 11. I'm wondering whether this is just an immunobody or something a bit different and whether there's any new IP around it. If so, who will own it?

I guess all that's important at this stage is the funding but it will be interesting to find out more.